FINELINE II

Report

• Report Number: 2124215-2010-17254
• Event Type: Injury
• Date Received: October 15, 2010
• Date of Event: August 24, 2010
• Report Date: August 24, 2010
• Manufacturer: CPI - DEL CARIBE
• Product Code: NVN
• Adverse Event: Yes
• Product Problem: Yes
• Report Source: Manufacturer report
• Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT EXPERIENCED FACIAL TRAUMA RESULTING FROM RIGHT VENTRICULAR (RV) LOSS OF CAPTURE (LOC). THE RV THRESHOLD MEASUREMENTS WERE FOUND TO BE ELEVATED. THE DEVICE OUTPUTS WERE INCREASED TO ASSURE RV CAPTURE, A LEAD REVISION WAS SCHEDULED. THIS LEAD WAS EXPLANTED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. TO DATE, NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	FINELINE II	IMPLANTABLE LEAD	NVN	CPI - DEL CARIBE	4456

Patients

Seq	Age	Sex	Outcome	Treatment
1	81 YR		Life Threatening| R	4136| S601| 4456

Terms

Patient problem · 1

• Fall

Product problems · 1

• Failure to Capture

Source type · 1

• Company representation

Type of report · 1

• Initial submission